Gender effects on intramuscular interferon beta-1a in relapsing–remitting multiple sclerosis: analysis of 1406 patients

• Published in: Multiple sclerosis Vol. 17; no. 3; pp. 353 - 360
• Main Authors: Rudick, RA, Kappos, L, Kinkel, R, Clanet, M, Phillips, JT, Herndon, RM, Sandrock, AW, Munschauer, FE
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-03-2011; Sage Publications Ltd
• Subjects: Adjuvants, Immunologic - administration & dosage; Adjuvants, Immunologic - adverse effects; Chi-Square Distribution; Disability Evaluation; Disease Progression; Female; Humans; Injections, Intramuscular; Interferon beta-1a; Interferon-beta - administration & dosage; Interferon-beta - adverse effects; Kaplan-Meier Estimate; Logistic Models; Magnetic Resonance Imaging; Male; Multiple Sclerosis, Relapsing-Remitting - diagnosis; Multiple Sclerosis, Relapsing-Remitting - drug therapy; Odds Ratio; Proportional Hazards Models; Risk Assessment; Risk Factors; Sex Factors; Time Factors; Treatment Outcome; IM IFNβ-1a; Adverse events; annualized relapse rate; multiple sclerosis; neutralizing antibodies; disability progression; clinically isolated syndrome; gadolinium-enhanced lesions; relapsing-remitting multiple sclerosis
• ISSN: 1352-4585; 1477-0970
• DOI: 10.1177/1352458510384605

Background: We aimed to evaluate effects of gender on efficacy and safety of intramuscular (IM) interferon beta (IFNβ)-1a in patients with relapsing–remitting MS (RRMS) or clinically isolated syndromes (CIS) characteristic of early MS.
Methods: Pooled data from 1406 (1027 women; 379 men) patients enrolled in five clinical studies of IM IFNβ-1a were analyzed. One analysis examined data for all patients treated with IM IFNβ-1a from all studies. Separate analyses were conducted of pooled IM IFNβ-1a-treated groups from all studies and pooled IFNβ-1a-treated and placebo-treated patients from the placebo-controlled studies. Outcome measures included time to first relapse, annualized relapse rate, time to disability progression, number of gadolinium-enhanced lesions, adverse events, laboratory evaluations, and neutralizing antibodies.
Results: All efficacy assessments indicated similar treatment effects of IM IFNβ-1a in men and women with no significant treatment-by-gender interactions. Women reported more headaches, urinary tract infections, and depression in the analysis; however, these were also common in women who received placebo. Men reported more frequent flu-like symptoms in the placebo-controlled studies only. There were no other differences in the safety profile of IM IFNβ-1a between men and women.
Conclusions: We conclude that no significant gender-related differences were found in the efficacy and safety of IM IFNβ-1a in patients with RRMS or CIS.